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DE – Hexal v. Eli Lilly – Pemexetred – Invalidity

22 Nov 2018

Hexal AG and Stada Artzneimittel AG v. Eli Lilly and Company, Federal Patent Court, Germany, 17 July 2018, Case no. 3 Ni 23/16 (EP) joined with 3 Ni 19/17 (EP), with thanks to Dr. Michael Best from Lederer & Keller, for providing the decision and an English translation thereof

This blog has covered the pemetrexed cases all over Europe (DenmarkSwitzerland, The Netherlands, ItalyAustriaUnited Kingdom).

Most of these decisions concern the question of infringement of the Eli Lilly patent EP 1 313 508 (EP‘508) which relates to the use of the active ingredient pemetrexed in combination therapy with vitamin B12 and optionally folic acid (formulated as a so-called Swiss-type claim).

Generic competitors and Eli Lilly have fought this battle in many jurisdictions. The discussion has in many cases been focused on the doctrine of equivalence. Also the German Federal Court of Justice (Bundesgerichtshof) has ruled that the generic product is an infringement of EP‘508 (the decision can be found here.) Now the Federal Patent Court in Germany has revoked the German part of EP‘508 in its decision of July 17, 2018.

The Federal Patent Court has decided that EP’508 is not based on an inventive step over the prior art cited in the nullity proceedings. The teaching of EP’508 is therefore obvious in the eyes of the German court. Basis for this conclusion were a combination of previously published articles which served as prior art for the Federal Patent Court. Eli Lilly also filed 9 auxiliary requests in which they further limited the scope of the patent. Each of those requests failed as the Federal Patent Court also deemed them as being obvious over the prior art.

Interestingly the EP’508 had survived opposition proceedings before the EPO. However, the Federal Patent Court explained in its decision that it is not in contradiction with those opposition proceedings as the prior art in the two proceedings differed. The prior art documents which the Federal Patent Court used to argue against inventive step were in that combination not part of the proceedings before the EPO. The Federal Patent Court also explained that it is not in contradiction to the existing German infringement cases which have not stayed the proceedings, as those infringement proceedings based their assumption on the decision of the EPO.

It is almost certain that this decision of the Federal Patent Court will be reviewed in appeal. Such an appeal is handled by the Federal Court of Justice who already had a look at this patent when they decided on the infringement case.

A copy of the decision of the Federal Patent Court (in German) can be found here. A translation of this decision can be found here.

Reported by Alexander Haertel, Kather Augenstein Rechtsanwälte